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Study of Sivelestat Sodium in OPCABG

NCT07118930 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 62

Last updated 2025-08-12

No results posted yet for this study

Summary

The goal of this clinical trial is to learn if drug Sivelestat Sodium works to improve the prognosis of off-pump coronary artery bypass grafting (OPCABG) in adults. It will also learn about the safety of drug Sivelestat Sodium. The main questions it aims to answer are:

* Does drug Sivelestat Sodium have a protective effect on myocardial injury after OPCABG?
* Does Sivelestat Sodium exert a protective effect on myocardial inflammatory stress after OPCABG? Researchers will compare drug Sivelestat Sodium to a placebo (a look-alike substance that contains no drug) to see if drug Sivelestat Sodium works to protect myocardium following OPCABG.

Participants will:

* Accept drug Sivelestat Sodium injection or a placebo 2 h after OPCABG for 72 h.
* Undergo a series of blood tests and echocardiography examinations after the OPCABG.

Conditions

Interventions

DRUG

Sivelestat Sodium injection 2 h after OPCABG for 72 h

Sivelestat Sodium injection 2 h after OPCABG for 72 h

DRUG

Saline (0.9% NaCl)

Saline (0.9% NaCl) instead of Sivelestat

Sponsors & Collaborators

  • Affiliated Hospital of Nantong University

    lead OTHER

Principal Investigators

  • Weizhang Xiao, Dr. · Affiliated Hospital of Nantong University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-08-01
Primary Completion
2027-07-31
Completion
2027-07-31

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07118930 on ClinicalTrials.gov